Age-Associated Memory Impairment
Conditions
Keywords
Mild Cognitive Impairment, Cognition disorders, nutritional supplement, dietary supplement
Brief summary
The purpose of this study is to determine whether tricaprilin, a compound that increases energy availability in the brain, improves memory in older adults with normal loss of memory abilities since early adult life.
Detailed description
One physiological hallmark of aging in mammals is a decreased uptake and metabolism of glucose within the brain. The impaired glucose metabolism in the brain may contribute or exacerbate the cognitive deficits observed during normal aging. Facilitation of memory in elderly individuals occurs when glucose levels are elevated by the administration of carbohydrate. However, such a treatment poses challenges since elevated blood glucose levels are difficult to maintain and must be within a relatively narrow window, as excessive hyperglycemia is associated with cognitive impairments. The purpose of this study is to explore whether increasing levels of other substrates for the brain improves cognitive functioning in normal aged individuals with memory disorders. Study participants will be 120 men and women aged 50-85 who have been diagnosed as having Age-Associated Memory Impairment (AAMI). During the double-blind period of the protocol, 60 participants will receive tricaprilin and 60 participants will receive a matching placebo. Tricaprilin or the matching placebo will be administered once a day for ninety days by mixing powder in 8 ounces of a liquid. Each participant will be seen six (6) times: at Screening; Baseline; treatment days Days 30, 60, 90; and 14 days after the conclusion of treatment (Day 104).
Interventions
DRUGTricaprilin
Powder formulation will be mixed in a liquid (approximately 8 oz).
OTHERPlacebo
Powder formulation will be mixed in a liquid (approximately 8 oz).
Sponsors
Cerecin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Complaints that memory has declined since young adult life * Scores on standardized tests that are at least one standard deviation below the mean score of young adults
Exclusion criteria
* Dementia, including Alzheimer's disease and Mild Cognitive Impairment (MCI) * Drugs that impair cognition * Psychiatric conditions that may impair cognition (e.g.,depression etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Psychologix and Cogscreen Test Batteries, RAVLT (Rey Auditory Verbal Learning Test) | 90 days | — |
| Number of subjects with treatment related adverse events | 90 days | AE incidence rate per treatment group |
Secondary
| Measure | Time frame |
|---|---|
| Self-reported memory improvement | 90 days |
Countries
United States
Outcome results
None listed